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U.S. Department of Health and Human Services

Class 2 Device Recall Sigma Pacemaker

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 Class 2 Device Recall Sigma Pacemakersee related information
Date Initiated by FirmNovember 29, 2005
Date PostedFebruary 18, 2006
Recall Status1 Terminated 3 on January 04, 2007
Recall NumberZ-0539-06
Recall Event ID 34093
PMA NumberP980035S002 
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
ProductSigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only.
Code Information Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SVVI103: serial no.PJG159902H - PJG176701H, PJG432779H - PJG432895H, PJG230582M - PJG236398M, PJG677442S - PJG696014S, PJG748310S - PJG755468S, PJG747654C - PJG755171C.
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Fridley MN 55432
For Additional Information ContactTim Samsel
763-505-7831
Manufacturer Reason
for Recall
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.
FDA Determined
Cause 2
Other
ActionPress Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.
Quantity in Commerce2,989
DistributionNationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = DXY
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